Johnson & Johnson and Legend Biotech's additional investment comes just as the so-called Tech Lane facility is set to begin clinical production of Carvykti in a few weeks.
On track to meet their long-stated capacity goal for multiple myeloma therapy Carvykti in 2025, Johnson & Johnson and Legend Biotech are already planning the next phase of their cell therapy manufacturing expansion.Based on internal projections for demand, the two companies have approved about $150 million in additional investments to expand the future capacity of a brand-new facility in Ghent, Belgium, Legend CEO Ying Huang, Ph.D., and interim Chief Financial Officer Jessie Yeung said on an investor call Tuesday.J&J and Legend decided on the new investment just as the so-called Tech Lane facility is set to begin clinical production of Carvykti in a few weeks. The site is expected to gain approval to initiate commercial supply by the end of 2025, according to Huang.For the latest expansion, early engineering and design work has begun, and construction is slated to start in the second half of 2025 and expected to be complete in 2028, Yeung said. The addition will primarily provide supplies for the EU market, a Legend spokesperson told Fierce Pharma.Over the last several years, J&J and Legend have been busy working to ramp up their cell therapy manufacturing capacity. Since Carvykti’s initial FDA approval in early 2022, supply constraints have limited the CAR-T therapy’s revenue growth. What’s more, an expanded FDA nod in April 2024 in second-line multiple myeloma roughly tripled the med’s eligible patient population.In one of the pair’s recent efforts to boost supply, contract manufacturer Novartis recently won FDA approval to make commercial supply of Carvykti at its site in Morris Plains, New Jersey, Huang said on the call. Also in New Jersey, J&J and Legend said in the fall of 2022 that they would double the investment in their flagship Raritan manufacturing facility to a total of $500 million. Legend now expects regulatory approval of a new section at that site in the second half of this year.The companies have another site in Ghent, called the Obelisc facility, which began commercial production in the third quarter of 2024 and is now operating at full capacity, according to Legend.These recent expansions will help the companies reach a capacity to be able to produce 10,000 doses of Carvykti on an annualized basis this year, a goal that was outlined in 2023.“By the end of this year, we’ll be in a situation where supply is fully meeting the demand where we are, and then we’ll be able to keep pace,” Alan Bash, Legend’s president of Carvykti, said on Tuesday’s call. But as analysts noted on the call, Wall Street’s 2026 consensus sales projection for Carvykti indicates that market watchers were unsure about whether patient demand will start to taper off.As of Tuesday, Carvykti can be administered at 104 certified treatment centers in the U.S. Meanwhile, growing levels of administration in the outpatient setting—and increased use at community practices—offer “significant upside” to the drug's growth trajectory, Bash said.Recipients of CAR-T therapies need to be monitored for the potentially life-threatening side effect of cytokine release syndrome. Because of Carvykti’s delayed onset of te syndrome, community providers are able to utilize outpatient administration, thereby freeing up limited inpatient space.This factor can help increase overall treatment capacity and therefore boost demand. The proportion of outpatient Carvykti use has increased from about 30% a year ago to more than 50% today, according to Bash.J&J and Legend have a three-stage plan to increase adoption in the community setting, where most multiple myeloma patients are treated. Right now, the drugmakers are reaching out to more than 8,000 community oncologists to educate them on Carvykti and to help them refer patients to certified treatment centers.In the second stage, starting later this year, the pair will identify certain regional hospitals and community accounts that are closely affiliated with large hospitals to administer Carvykti on-site, Bash said. For the third stage, which will begin next year, the goal is to have the drug more widely administered in community oncology practices, he added. Looming competition Another key reason analysts have reservations about Carvykti in 2026 is the expected entry of Gilead Sciences and Arcellx’s rival BCMA CAR-T anito-cel. In a pivotal phase 2 trial in late-line myeloma, anito-cel showed what analysts viewed as competitive efficacy and better safety to Carvykti, with the important caveat that cross-trial comparisons carry inherent flaws.On Tuesday’s call, Huang played down the potential threat of anito-cel for Carvykti in 2026. When approved, anito-cel would be entering the late-line setting, whereas the majority of Carvykti’s revenue mix will come from earlier lines, he argued. By the end of 2025, Legend expects about two-thirds to three-quarters of Carvykti revenue will come from second- to fourth-line treatment, he said.In anito-cel's phase 2 trial, one factor that stood out for the drug was the absence of some delayed neurotoxicities, including Parkinsonism, which has recently emerged as a concern for Carvykti. During Tuesday’s call, Legend executives pointed to a recent single-site study by the Colorado Blood Cancer Institute. The small study of 39 patients suggested that unrestrained absolute lymphocyte count (ALC) expansion is predictable of neurotoxicites following Carvykti treatment and that prophylactic treatment with the steroid dexamethasone may be able to mitigate the effect. The study did not separate delayed neurotoxocities from other neurologic complications.Legend is talking to multiple centers to potentially study this phenomenon in an investigator-initiated trial, and it has incorporated the mitigation strategy into ongoing Cartitude trial programs for Carvykti, Chief Medical Officer Mythili Koneru, M.D., Ph.D., said on Tuesday’s call.As to the real world, Koneru noted that an ALC-based monitoring and mitigation strategy is easily applicable, because it’s “a very typical lab result that is checked very frequently and commonly at all centers, including academic centers as well as in a community setting.”
